Device
The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically, - Pumps blood through the blood flow path...
Manufacturer
I-Dialco Inc
I-Dialco Inc
Model: DM-850-00
DI: 07540161930004
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically, - Pumps blood through the blood flow path of the disposable cassette, - Delivers anticoagulant into the blood flow path, - Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use, - Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies, - Controls the patient fluid removal or plasma loss according to the therapy in use, - Monitors the system and alerts the operator of abnormal situations through alarms. The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eea28206-4f18-40bf-97c4-56abe08f9ca9
Distribution Status:
In Commercial Distribution
DUNS Number:
243307430
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07540161930004
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58131
Name: Haemodialysis system, institutional/home-use
Definition:
An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.
FDA Product Codes
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System